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The purpose of the proposed pilot randomized controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a videoconferencing-based individual Acceptance and Commitment Therapy (ACT) approach to enhance the mental well-being and parenting competence of parents of children with hearing loss post-cochlear implantation over a three-month period after the intervention has taken place.
Full description
Caregivers of children with hearing loss post-cochlear implantation (CI), experience sustained caregiving demands that place them at elevated risk for stress, anxiety, depressive symptoms, and reduced family functioning. The postoperative journey commonly involves intensive device mapping, auditory-verbal therapy, daily home-based training, and frequent medical or rehabilitation appointments. These demands, coupled with uncertainty about the child's auditory, speech, and psychosocial outcomes, can erode caregiver well-being and strain family routines. Evidence across populations indicates that psychoeducational and psychotherapeutic interventions can improve caregiver mental health and parenting efficacy by providing knowledge, skills, and strategies that enhance coping and resilience.
Acceptance and Commitment Therapy (ACT) and related third-wave approaches have shown benefits for parents of children with chronic conditions by increasing psychological flexibility-an empirically supported process linked to improved mental health and adaptive caregiving. However, prior trials in similar caregiver populations have sometimes yielded modest effect sizes, in part due to high resource requirements (e.g., reliance on extensively trained therapists) and insufficient focus on the most impaired transdiagnostic processes (e.g., cognitive fusion, experiential avoidance, values-behavior disconnect). In addition, access barriers (time, travel, childcare) limit uptake of in-person programs, especially for families navigating intensive post CI rehabilitation schedules.
This pilot randomized controlled trial (RCT) will evaluate the feasibility, acceptability, and preliminary effectiveness of an online psychoeducational and psychotherapeutic programme tailored for caregivers of children with hearing loss following cochlear implantation. The programme integrates two complementary components: (1) targeted psychoeducation on post CI care (device use and troubleshooting, auditory rehabilitation at home, realistic progress monitoring, school and social participation, communication strategies, and navigation of rehabilitation services); and (2) brief, skills focused psychotherapeutic content grounded in ACT principles to enhance psychological flexibility (e.g., present moment awareness, defusion from difficult thoughts, acceptance of difficult emotions and sensations, values clarification, and committed action in daily caregiving). By combining condition specific knowledge with process based skills, the intervention is designed to address both informational needs and core psychopathological processes that perpetuate caregiver distress.
The programme will be delivered via secure videoconferencing in a structured, time limited format to reduce burden and improve accessibility. Sessions will include didactic micro modules, guided experiential exercises (e.g., mindfulness, values mapping, defusion techniques), and applied practice tied to real world caregiving tasks (e.g., integrating values into daily listening practice, using brief acceptance/defusion skills during child resistance to wear time, and problem solving around school or therapy transitions). Between-session activities will reinforce learning through short videos, worksheets, and practice logs. Content will be developmentally and culturally adapted for families of children using CIs, with attention to diverse communication modalities and family preferences.
Participants will be randomly assigned to the online programme or a waitlist control. Outcome assessments will occur at baseline (pre intervention) and immediately post intervention. Primary feasibility and acceptability metrics will include recruitment, retention, session attendance, completion of between session activities, and participant-rated satisfaction and perceived usefulness. Preliminary effectiveness outcomes will focus on caregiver mental health and functioning (e.g., stress, anxiety/depressive symptoms, psychological flexibility, and parenting self efficacy). Exploratory outcomes will include family functioning, adherence to home auditory verbal practice, and caregiver reported child participation in everyday listening and communication activities.
We hypothesize that the online programme will be feasible and acceptable to caregivers and will yield greater improvements than usual-care-only control in caregiver mental health, psychological flexibility, and parenting self-efficacy from baseline to post intervention. By using a brief, process based approach and remote delivery, the intervention aims to lessen reliance on scarce specialist time, reduce participation barriers, and target the mechanisms most closely linked to caregiver distress. Findings from this pilot will inform refinement of content, dosing, and implementation strategies, and will provide effect size estimates to power a future full scale RCT.
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64 participants in 2 patient groups
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Sini LI, PhD
Data sourced from clinicaltrials.gov
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